Government: Page 69
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FDA issues action plan for regulating AI in medical devices
The proposal brings the agency a step closer to draft guidance for regulating the fast-evolving field of artificial intelligence and machine learning-based software in medical devices.
By Susan Kelly • Jan. 14, 2021 -
ACA plan enrollment for 2021 ticked up slightly
Of the total, 23% of consumers were new and the rest renewed coverage. Repeat consumers who actively chose a new plan and those who were automatically re-enrolled both increased.
By Shannon Muchmore • Jan. 14, 2021 -
Trendline
Labor
Hospitals are navigating persistent labor shortages with the need to cut costs — a source of contention that could leave patients caught in the middle.
By Healthcare Dive staff -
CMS breakthrough rule cheered as tailwind for Abbott, J&J and Medtronic
The final rule enables developers of FDA-designated breakthrough products to get Medicare coverage for some 60 million beneficiaries on the day they win approval.
By Nick Paul Taylor • Jan. 13, 2021 -
Samantha Liss, Healthcare Dive
OpinionCare navigation during COVID-19 and beyond
The industry needs to quickly come up with a way to prevent and mitigate enduring health issues for COVID-19 survivors as well as catch up on deferred care for other conditions, Harvard Medical School's Sanjay Basu argues.
By Sanjay Basu • Jan. 12, 2021 -
CMS audits small slice of hospitals for price transparency, probes complaints
Compliance is "frustratingly incomplete," said Niall Brennan, CEO of the Health Care Cost Institute. A paltry $300 daily fine may not be enough to force facilities to reveal the information.
By Samantha Liss • Jan. 11, 2021 -
Courtesy of Novavax, Australian Broadcasting Corporation
AHA to HHS: Feds need to take charge in COVID-19 vaccine rollout
The plea coming less than two weeks before the Biden administration takes over suggests the urgency. "As this rollout rapidly evolves, it is absolutely critical that effective situational, real-time leadership is provided nationally."
By Ron Shinkman • Jan. 8, 2021 -
Brian Tucker/Healthcare Dive
Tennessee approved for first Medicaid block grant program
The waiver is approved for 10 years. The incoming Biden administration could attempt to roll it back, but the state would be able to challenge such a move.
By Shannon Muchmore • Jan. 8, 2021 -
Alex Wong via Getty Images
HHS finalizes regulatory review rule, though more lenient than proposed
When pitched in November, the idea sparked concern among providers and other groups fearing it would inject more uncertainty into the industry, and heap additional administrative burden onto HHS.
By Rebecca Pifer • Jan. 8, 2021 -
Retrieved from Gage Skidmore/Flickr.
With Democratic trifecta, Biden could shore up ACA
"A lot can be done with a simple majority vote in the Senate," Kaiser Family Foundation's Larry Levitt said on Twitter.
By Shannon Muchmore • Jan. 7, 2021 -
Alex Wong via Getty Images
Not enough time, not enough clarity: Payers push back on CMS prior authorization rule
Following publication on the Federal Register, industry groups had only 17 days to review the rule and draft comments — a major source of concern, insurers said.
By Rebecca Pifer • Jan. 6, 2021 -
Permission granted by University of Maryland School of Medicine
FDA says changing coronavirus vaccine dosing could put 'public health at risk'
In an unusual statement, FDA chief Stephen Hahn and top official Peter Marks opposed altering vaccination regimens without further evidence, calling proposals to do so "premature."
By Ben Fidler • Jan. 5, 2021 -
CMS should tweak wage index adjustment to help rural hospitals, OIG says
The report, issued following a federal audit, found rural hospitals had the highest concentration of low-wage providers. Of all hospitals in the bottom quartile of area wage indexes, 53% were operating in rural areas.
By Rebecca Pifer • Jan. 4, 2021 -
AHA seeks emergency relief to block enforcement of price transparency rule
Imminent enforcement "will force overburdened hospitals to divert resources that hospitals desperately need to respond to the surge of COVID-19 cases and successfully roll out the vaccines," the hospital lobby argued.
By Samantha Liss • Dec. 23, 2020 -
CMS finalizes rule to ease value-based arrangements for prescription drugs
The changes, effective in 2022, overhaul existing regulations that stymied value-based payments in a bid to expand access to new, expensive drugs like gene therapies, the agency said.
By Rebecca Pifer • Dec. 22, 2020 -
ACA exchange enrollment for 2021 holds steady
About a quarter signed up for a plan for the first time — amid historic job losses — while the rest were returning customers or people who were automatically re-enrolled.
By Shannon Muchmore • Dec. 21, 2020 -
Moderna's first FDA clearance brings the US a second coronavirus vaccine
The FDA's emergency authorization of the biotech's shot bolsters an immunization campaign in the U.S. that's just beginning.
By Ben Fidler • Dec. 18, 2020 -
CMS greenlights direct contracting model for Medicaid MCOs, dual eligibles
The possibility of shared savings may spur managed care companies to make new investments in coordinated care to ultimately curb costs in Medicare fee-for-service, the agency said.
By Samantha Liss • Dec. 18, 2020 -
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days.
By Ned Pagliarulo • Updated Dec. 17, 2020 -
Hospital costs drove 2019 health spending, CMS analysis finds
Researchers warned next year's report is expected to look quite different, as the pandemic "will certainly have profound consequences on the provision and consumption of health care in 2020 and perhaps beyond."
By Hailey Mensik • Dec. 17, 2020 -
Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic
BinaxNOW requires a prescription and a telehealth service to take users through collection. However, public health experts question why prescriptions are being required at all for such tests.
By Greg Slabodkin • Dec. 17, 2020 -
Permission granted by University of Maryland School of Medicine
COVID-19 vaccine supply chain has cyberthreats hidden in plain sight
Outdated systems throughout vaccine distribution logistics carry unprecedented cyberthreats.
By Samantha Schwartz • Dec. 17, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA advisers meet to review Moderna's coronavirus vaccine
Support from the advisory committee Thursday would likely result in an emergency authorization for the shot within days. Track the meeting's progress here.
By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • Updated Dec. 17, 2020 -
Permission granted by E.A. Crunden
HHS starts doling out $25B in third phase of CARES provider funding
The amount exceeds the original $20 billion planned for this tranche, as officials realized more would be needed to get providers close to whole from coronavirus-related losses.
By Shannon Muchmore • Dec. 16, 2020 -
Szekely, Pedro. (2017). "Chicago skyline" [Photograph]. Retrieved from Flickr.
Illinois health regulators block Mercy hospital closure
The hospital on Chicago's South Side wanted to end inpatient services, but a board shot down the plans amid the COVID-19 pandemic. Health system executives want to pivot to an outpatient model of care.
By Samantha Liss • Dec. 16, 2020 -
FDA grants emergency approval for first fully at-home COVID-19 test without prescription
The rapid antigen test from Australian company Ellume will be available over the counter for people with or without symptoms and delivers results in about 20 minutes.
By Susan Kelly • Dec. 16, 2020
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